Trial Outcomes & Findings for Mini-Dose Glucagon to Treat Non-Severe Hypoglycemia (NCT NCT02411578)

NCT ID: NCT02411578

Last Updated: 2020-03-03

Results Overview

• Recruitment status: COMPLETED
• Study phase: PHASE2
• Target enrollment: 26 participants
• Primary outcome timeframe: 30 minutes
• Results posted on: 2020-03-03

Participant Flow

26 consented for Run-in; 1 ineligible after consent; 2 ineligible after Run-in phase; 3 withdrew

Participant milestones

Measure	G-Pen Mini™ (Glucagon Injection), Then Glucose Tabs For G-Pen Mini Period: Participants are to check blood glucose (BG) with study meter if continuous glucose monitor (CGM) reads \<70 mg/dl or they experience symptoms. Participants instructed to treat using mini-dose glucagon for certain phases/periods when BG is 40 to 69 mg/dl (considered a non-severe hypoglycemic event). G-Pen Mini™ (glucagon injection): 1st BG check, 1st treatment 1. BG is 50-69 mg/dl, treatment is 150 µg of glucagon 2. BG is 40-49 mg/dl, treatment is 300 µg of glucagon 15 min later, 2nd BG check, 2nd treatment 1. BG is 60-69 mg/dl, no treatment 2. BG is 50-59 mg/dl, treatment is 150 µg of glucagon 3. BG is \<50 mg/dl, treatment is participant's preferred oral carbohydrate and not mini-dose glucagon 30 minutes later, 3rd BG check, 3rd treatment 1. BG is \>=70, no treatment 2. BG is \<70 mg/dl, treatment is participant's preferred oral carbohydrate and not mini-dose glucagon	Glucose Tabs, Then G-Pen Mini For Glucose Tabs Period: Participants are to check blood glucose (BG) with study meter if continuous glucose meter reads \<70 mg/dl or they experience symptoms. Participants instructed to treat using oral glucose tablets for certain phases/periods when BG is 40 to 69 mg/dl (considered a non-severe hypoglycemic event). Glucose Tabs: 1st BG check, 1st treatment: 1. BG is 50-69 mg/dl, treatment is 15 grams of carbohydrates 2. BG is 40-49 mg/dl, treatment is 30 grams of carbohydrates 15 min later, 2nd BG check, 2nd treatment 1. BG is 60-69 mg/dl, no treatment 2. BG is 50-59 mg/dl, treatment is 15 grams of carbohydrates 3. BG is \<50 mg/dl, treatment is participant's preferred oral carbohydrate and not mini-dose glucagon 30 minutes later, 3rd BG check, 3rd treatment 1. BG is \>=70 mg/dl, no treatment 2. BG is \<70 mg/dl, treatment is participant's preferred oral carbohydrate and not mini-dose glucagon
Crossover Trial Phase STARTED	8	12
Crossover Trial Phase COMPLETED	8	11
Crossover Trial Phase NOT COMPLETED	0	1
Extension Phase STARTED	8	9
Extension Phase COMPLETED	8	9
Extension Phase NOT COMPLETED	0	0

Reasons for withdrawal

Measure	G-Pen Mini™ (Glucagon Injection), Then Glucose Tabs For G-Pen Mini Period: Participants are to check blood glucose (BG) with study meter if continuous glucose monitor (CGM) reads \<70 mg/dl or they experience symptoms. Participants instructed to treat using mini-dose glucagon for certain phases/periods when BG is 40 to 69 mg/dl (considered a non-severe hypoglycemic event). G-Pen Mini™ (glucagon injection): 1st BG check, 1st treatment 1. BG is 50-69 mg/dl, treatment is 150 µg of glucagon 2. BG is 40-49 mg/dl, treatment is 300 µg of glucagon 15 min later, 2nd BG check, 2nd treatment 1. BG is 60-69 mg/dl, no treatment 2. BG is 50-59 mg/dl, treatment is 150 µg of glucagon 3. BG is \<50 mg/dl, treatment is participant's preferred oral carbohydrate and not mini-dose glucagon 30 minutes later, 3rd BG check, 3rd treatment 1. BG is \>=70, no treatment 2. BG is \<70 mg/dl, treatment is participant's preferred oral carbohydrate and not mini-dose glucagon	Glucose Tabs, Then G-Pen Mini For Glucose Tabs Period: Participants are to check blood glucose (BG) with study meter if continuous glucose meter reads \<70 mg/dl or they experience symptoms. Participants instructed to treat using oral glucose tablets for certain phases/periods when BG is 40 to 69 mg/dl (considered a non-severe hypoglycemic event). Glucose Tabs: 1st BG check, 1st treatment: 1. BG is 50-69 mg/dl, treatment is 15 grams of carbohydrates 2. BG is 40-49 mg/dl, treatment is 30 grams of carbohydrates 15 min later, 2nd BG check, 2nd treatment 1. BG is 60-69 mg/dl, no treatment 2. BG is 50-59 mg/dl, treatment is 15 grams of carbohydrates 3. BG is \<50 mg/dl, treatment is participant's preferred oral carbohydrate and not mini-dose glucagon 30 minutes later, 3rd BG check, 3rd treatment 1. BG is \>=70 mg/dl, no treatment 2. BG is \<70 mg/dl, treatment is participant's preferred oral carbohydrate and not mini-dose glucagon
Crossover Trial Phase Pregnancy	0	1

Baseline Characteristics

Mini-Dose Glucagon to Treat Non-Severe Hypoglycemia

Baseline characteristics by cohort

Measure	G-Pen Mini™ (Glucagon Injection), Then Glucose Tabs n=6 Participants For G-Pen Mini Period: Participants are to check blood glucose (BG) with study meter if continuous glucose monitor (CGM) reads \<70 mg/dl or they experience symptoms. Participants instructed to treat using mini-dose glucagon for certain phases/periods when BG is 40 to 69 mg/dl (considered a non-severe hypoglycemic event). G-Pen Mini™ (glucagon injection): 1st BG check, 1st treatment 1. BG is 50-69 mg/dl, treatment is 150 µg of glucagon 2. BG is 40-49 mg/dl, treatment is 300 µg of glucagon 15 min later, 2nd BG check, 2nd treatment 1. BG is 60-69 mg/dl, no treatment 2. BG is 50-59 mg/dl, treatment is 150 µg of glucagon 3. BG is \<50 mg/dl, treatment is participant's preferred oral carbohydrate and not mini-dose glucagon 30 minutes later, 3rd BG check, 3rd treatment 1. BG is \>=70, no treatment 2. BG is \<70 mg/dl, treatment is participant's preferred oral carbohydrate and not mini-dose glucagon	Glucose Tabs, Then G-Pen Mini n=10 Participants For Glucose Tabs Period: Participants are to check blood glucose (BG) with study meter if continuous glucose meter reads \<70 mg/dl or they experience symptoms. Participants instructed to treat using oral glucose tablets for certain phases/periods when BG is 40 to 69 mg/dl (considered a non-severe hypoglycemic event). Glucose Tabs: 1st BG check, 1st treatment: 1. BG is 50-69 mg/dl, treatment is 15 grams of carbohydrates 2. BG is 40-49 mg/dl, treatment is 30 grams of carbohydrates 15 min later, 2nd BG check, 2nd treatment 1. BG is 60-69 mg/dl, no treatment 2. BG is 50-59 mg/dl, treatment is 15 grams of carbohydrates 3. BG is \<50 mg/dl, treatment is participant's preferred oral carbohydrate and not mini-dose glucagon 30 minutes later, 3rd BG check, 3rd treatment 1. BG is \>=70 mg/dl, no treatment 2. BG is \<70 mg/dl, treatment is participant's preferred oral carbohydrate and not mini-dose glucagon	Total n=16 Participants Total of all reporting groups
Age, Continuous	41.5 years STANDARD_DEVIATION 9.1 • n=93 Participants	36.9 years STANDARD_DEVIATION 12.2 • n=4 Participants	38.6 years STANDARD_DEVIATION 11.0 • n=27 Participants
Sex: Female, Male Female	3 Participants n=93 Participants	9 Participants n=4 Participants	12 Participants n=27 Participants
Sex: Female, Male Male	3 Participants n=93 Participants	1 Participants n=4 Participants	4 Participants n=27 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	0 Participants n=93 Participants	0 Participants n=4 Participants	0 Participants n=27 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	6 Participants n=93 Participants	10 Participants n=4 Participants	16 Participants n=27 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=93 Participants	0 Participants n=4 Participants	0 Participants n=27 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=93 Participants	0 Participants n=4 Participants	0 Participants n=27 Participants
Race (NIH/OMB) Asian	0 Participants n=93 Participants	0 Participants n=4 Participants	0 Participants n=27 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=93 Participants	0 Participants n=4 Participants	0 Participants n=27 Participants
Race (NIH/OMB) Black or African American	0 Participants n=93 Participants	0 Participants n=4 Participants	0 Participants n=27 Participants
Race (NIH/OMB) White	6 Participants n=93 Participants	10 Participants n=4 Participants	16 Participants n=27 Participants
Race (NIH/OMB) More than one race	0 Participants n=93 Participants	0 Participants n=4 Participants	0 Participants n=27 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=93 Participants	0 Participants n=4 Participants	0 Participants n=27 Participants
Hemoglobin A1c	6.9 % STANDARD_DEVIATION 0.6 • n=93 Participants	7.4 % STANDARD_DEVIATION 0.9 • n=4 Participants	7.2 % STANDARD_DEVIATION 0.8 • n=27 Participants
Duration of Type 1 Diabetes	24.8 years STANDARD_DEVIATION 14.2 • n=93 Participants	22.5 years STANDARD_DEVIATION 15.8 • n=4 Participants	23.4 years STANDARD_DEVIATION 14.8 • n=27 Participants

PRIMARY outcome

Timeframe: 30 minutes

Population: Limited to events with starting BG of 50-69 mg/dL

Outcome measures

Measure	G-Pen Mini™ (Glucagon Injection) n=62 Hypoglycemic Events For G-Pen Mini period: Participants are to check blood glucose (BG) with study meter if continuous glucose monitor (CGM) reads \<70 mg/dl or they experience symptoms. Participants instructed to treat using mini-dose glucagon for certain phases/periods when BG is 40 to 69 mg/dl (considered a non-severe hypoglycemic event). G-Pen Mini™ (glucagon injection): 1st BG check, 1st treatment 1. BG is 50-69 mg/dl, treatment is 150 µg of glucagon 2. BG is 40-49 mg/dl, treatment is 300 µg of glucagon 15 min later, 2nd BG check, 2nd treatment 1. BG is 60-69 mg/dl, no treatment 2. BG is 50-59 mg/dl, treatment is 150 µg of glucagon 3. BG is \<50 mg/dl, treatment is participant's preferred oral carbohydrate and not mini-dose glucagon 30 minutes later, 3rd BG check, 3rd treatment 1. BG is \>=70, no treatment 2. BG is \<70 mg/dl, treatment is participant's preferred oral carbohydrate and not mini-dose glucagon	Glucose Tabs n=56 Hypoglycemic Events For Glucose Tabs Period: Participants are to check blood glucose (BG) with study meter if continuous glucose meter reads \<70 mg/dl or they experience symptoms. Participants instructed to treat using oral glucose tablets for certain phases/periods when BG is 40 to 69 mg/dl (considered a non-severe hypoglycemic event). Glucose Tabs: 1st BG check, 1st treatment: 1. BG is 50-69 mg/dl, treatment is 15 grams of carbohydrates 2. BG is 40-49 mg/dl, treatment is 30 grams of carbohydrates 15 min later, 2nd BG check, 2nd treatment 1. BG is 60-69 mg/dl, no treatment 2. BG is 50-59 mg/dl, treatment is 15 grams of carbohydrates 3. BG is \<50 mg/dl, treatment is participant's preferred oral carbohydrate and not mini-dose glucagon 30 minutes later, 3rd BG check, 3rd treatment 1. BG is \>=70 mg/dl, no treatment 2. BG is \<70 mg/dl, treatment is participant's preferred oral carbohydrate and not mini-dose glucagon
Number of Hypoglycemic Events ≥50 mg/dl 15 Minutes AND ≥ 70 mg/dl 30 Minutes After Initial Treatment	58 Hypoglycemic Events	53 Hypoglycemic Events

SECONDARY outcome

Timeframe: 60 Minutes

Population: A participant had to have sufficient calibrations using study BGM to compare BGM and CGM data to ensure matching dates and times. Event level requirements: 1) initial treatment and dose had to be correct, 2) ≥6 CGM readings within 1 hour after initial treatment, and 3) first CGM glucose after the start of the hypoglycemic event had to be \<80 mg/dL

Minimum glucose from CGM data, following each hypoglycemic event with starting BG 50-69 mg/dL, during first hour after start of hypoglycemic event

Outcome measures

Measure	G-Pen Mini™ (Glucagon Injection) n=48 Hypoglycemic Events For G-Pen Mini period: Participants are to check blood glucose (BG) with study meter if continuous glucose monitor (CGM) reads \<70 mg/dl or they experience symptoms. Participants instructed to treat using mini-dose glucagon for certain phases/periods when BG is 40 to 69 mg/dl (considered a non-severe hypoglycemic event). G-Pen Mini™ (glucagon injection): 1st BG check, 1st treatment 1. BG is 50-69 mg/dl, treatment is 150 µg of glucagon 2. BG is 40-49 mg/dl, treatment is 300 µg of glucagon 15 min later, 2nd BG check, 2nd treatment 1. BG is 60-69 mg/dl, no treatment 2. BG is 50-59 mg/dl, treatment is 150 µg of glucagon 3. BG is \<50 mg/dl, treatment is participant's preferred oral carbohydrate and not mini-dose glucagon 30 minutes later, 3rd BG check, 3rd treatment 1. BG is \>=70, no treatment 2. BG is \<70 mg/dl, treatment is participant's preferred oral carbohydrate and not mini-dose glucagon	Glucose Tabs n=36 Hypoglycemic Events For Glucose Tabs Period: Participants are to check blood glucose (BG) with study meter if continuous glucose meter reads \<70 mg/dl or they experience symptoms. Participants instructed to treat using oral glucose tablets for certain phases/periods when BG is 40 to 69 mg/dl (considered a non-severe hypoglycemic event). Glucose Tabs: 1st BG check, 1st treatment: 1. BG is 50-69 mg/dl, treatment is 15 grams of carbohydrates 2. BG is 40-49 mg/dl, treatment is 30 grams of carbohydrates 15 min later, 2nd BG check, 2nd treatment 1. BG is 60-69 mg/dl, no treatment 2. BG is 50-59 mg/dl, treatment is 15 grams of carbohydrates 3. BG is \<50 mg/dl, treatment is participant's preferred oral carbohydrate and not mini-dose glucagon 30 minutes later, 3rd BG check, 3rd treatment 1. BG is \>=70 mg/dl, no treatment 2. BG is \<70 mg/dl, treatment is participant's preferred oral carbohydrate and not mini-dose glucagon
Continuous Glucose Monitor (CGM) Minimum Glucose, Event Level	59 mg/dL Interval 52.0 to 66.0	56 mg/dL Interval 52.0 to 60.0

SECONDARY outcome

Timeframe: 60 Minutes

Population: A participant had to have sufficient calibrations using study BGM to compare BGM and CGM data to ensure matching dates and times. Event level requirements: 1) initial treatment and dose had to be correct, 2) ≥6 CGM readings within 1 hour after initial treatment, and 3) first CGM glucose after the start of the hypoglycemic event had to be \<80 mg/dL

Maximum glucose from CGM data, following each hypoglycemic event with starting BG 50-69 mg/dL, during first hour after start of hypoglycemic event

Outcome measures

Measure	G-Pen Mini™ (Glucagon Injection) n=48 Hypoglycemic Events For G-Pen Mini period: Participants are to check blood glucose (BG) with study meter if continuous glucose monitor (CGM) reads \<70 mg/dl or they experience symptoms. Participants instructed to treat using mini-dose glucagon for certain phases/periods when BG is 40 to 69 mg/dl (considered a non-severe hypoglycemic event). G-Pen Mini™ (glucagon injection): 1st BG check, 1st treatment 1. BG is 50-69 mg/dl, treatment is 150 µg of glucagon 2. BG is 40-49 mg/dl, treatment is 300 µg of glucagon 15 min later, 2nd BG check, 2nd treatment 1. BG is 60-69 mg/dl, no treatment 2. BG is 50-59 mg/dl, treatment is 150 µg of glucagon 3. BG is \<50 mg/dl, treatment is participant's preferred oral carbohydrate and not mini-dose glucagon 30 minutes later, 3rd BG check, 3rd treatment 1. BG is \>=70, no treatment 2. BG is \<70 mg/dl, treatment is participant's preferred oral carbohydrate and not mini-dose glucagon	Glucose Tabs n=36 Hypoglycemic Events For Glucose Tabs Period: Participants are to check blood glucose (BG) with study meter if continuous glucose meter reads \<70 mg/dl or they experience symptoms. Participants instructed to treat using oral glucose tablets for certain phases/periods when BG is 40 to 69 mg/dl (considered a non-severe hypoglycemic event). Glucose Tabs: 1st BG check, 1st treatment: 1. BG is 50-69 mg/dl, treatment is 15 grams of carbohydrates 2. BG is 40-49 mg/dl, treatment is 30 grams of carbohydrates 15 min later, 2nd BG check, 2nd treatment 1. BG is 60-69 mg/dl, no treatment 2. BG is 50-59 mg/dl, treatment is 15 grams of carbohydrates 3. BG is \<50 mg/dl, treatment is participant's preferred oral carbohydrate and not mini-dose glucagon 30 minutes later, 3rd BG check, 3rd treatment 1. BG is \>=70 mg/dl, no treatment 2. BG is \<70 mg/dl, treatment is participant's preferred oral carbohydrate and not mini-dose glucagon
CGM Maximum Glucose, Event Level	102 mg/dL Interval 83.0 to 119.0	116 mg/dL Interval 98.0 to 143.0

SECONDARY outcome

Timeframe: 60 Minutes

Population: A participant had to have sufficient calibrations using study BGM to compare BGM and CGM data to ensure matching dates and times. Event level requirements: 1) initial treatment and dose had to be correct, 2) ≥6 CGM readings within 1 hour after initial treatment, and 3) first CGM glucose after the start of the hypoglycemic event had to be \<80 mg/dL

Median (IQR) reported for mean glucose from CGM data, following each hypoglycemic event with starting BG 50-69 mg/dL, during first hour after start of hypoglycemic event

Outcome measures

Measure	G-Pen Mini™ (Glucagon Injection) n=48 Hypoglycemic Events For G-Pen Mini period: Participants are to check blood glucose (BG) with study meter if continuous glucose monitor (CGM) reads \<70 mg/dl or they experience symptoms. Participants instructed to treat using mini-dose glucagon for certain phases/periods when BG is 40 to 69 mg/dl (considered a non-severe hypoglycemic event). G-Pen Mini™ (glucagon injection): 1st BG check, 1st treatment 1. BG is 50-69 mg/dl, treatment is 150 µg of glucagon 2. BG is 40-49 mg/dl, treatment is 300 µg of glucagon 15 min later, 2nd BG check, 2nd treatment 1. BG is 60-69 mg/dl, no treatment 2. BG is 50-59 mg/dl, treatment is 150 µg of glucagon 3. BG is \<50 mg/dl, treatment is participant's preferred oral carbohydrate and not mini-dose glucagon 30 minutes later, 3rd BG check, 3rd treatment 1. BG is \>=70, no treatment 2. BG is \<70 mg/dl, treatment is participant's preferred oral carbohydrate and not mini-dose glucagon	Glucose Tabs n=36 Hypoglycemic Events For Glucose Tabs Period: Participants are to check blood glucose (BG) with study meter if continuous glucose meter reads \<70 mg/dl or they experience symptoms. Participants instructed to treat using oral glucose tablets for certain phases/periods when BG is 40 to 69 mg/dl (considered a non-severe hypoglycemic event). Glucose Tabs: 1st BG check, 1st treatment: 1. BG is 50-69 mg/dl, treatment is 15 grams of carbohydrates 2. BG is 40-49 mg/dl, treatment is 30 grams of carbohydrates 15 min later, 2nd BG check, 2nd treatment 1. BG is 60-69 mg/dl, no treatment 2. BG is 50-59 mg/dl, treatment is 15 grams of carbohydrates 3. BG is \<50 mg/dl, treatment is participant's preferred oral carbohydrate and not mini-dose glucagon 30 minutes later, 3rd BG check, 3rd treatment 1. BG is \>=70 mg/dl, no treatment 2. BG is \<70 mg/dl, treatment is participant's preferred oral carbohydrate and not mini-dose glucagon
CGM Mean Glucose, Event Level	79 mg/dL Interval 69.0 to 91.0	87 mg/dL Interval 77.0 to 102.0

SECONDARY outcome

Timeframe: 60 Minutes

Population: A participant had to have sufficient calibrations using study BGM to compare BGM and CGM data to ensure matching dates and times. Event level requirements: 1) initial treatment and dose had to be correct, 2) ≥6 CGM readings within 1 hour after initial treatment, and 3) first CGM glucose after the start of the hypoglycemic event had to be \<80 mg/dL

Percentage of time 70-180 mg/dL from CGM data, following each hypoglycemic event with starting BG 50-69 mg/dL, during first hour after start of hypoglycemic event

Outcome measures

Measure	G-Pen Mini™ (Glucagon Injection) n=48 Hypoglycemic Events For G-Pen Mini period: Participants are to check blood glucose (BG) with study meter if continuous glucose monitor (CGM) reads \<70 mg/dl or they experience symptoms. Participants instructed to treat using mini-dose glucagon for certain phases/periods when BG is 40 to 69 mg/dl (considered a non-severe hypoglycemic event). G-Pen Mini™ (glucagon injection): 1st BG check, 1st treatment 1. BG is 50-69 mg/dl, treatment is 150 µg of glucagon 2. BG is 40-49 mg/dl, treatment is 300 µg of glucagon 15 min later, 2nd BG check, 2nd treatment 1. BG is 60-69 mg/dl, no treatment 2. BG is 50-59 mg/dl, treatment is 150 µg of glucagon 3. BG is \<50 mg/dl, treatment is participant's preferred oral carbohydrate and not mini-dose glucagon 30 minutes later, 3rd BG check, 3rd treatment 1. BG is \>=70, no treatment 2. BG is \<70 mg/dl, treatment is participant's preferred oral carbohydrate and not mini-dose glucagon	Glucose Tabs n=36 Hypoglycemic Events For Glucose Tabs Period: Participants are to check blood glucose (BG) with study meter if continuous glucose meter reads \<70 mg/dl or they experience symptoms. Participants instructed to treat using oral glucose tablets for certain phases/periods when BG is 40 to 69 mg/dl (considered a non-severe hypoglycemic event). Glucose Tabs: 1st BG check, 1st treatment: 1. BG is 50-69 mg/dl, treatment is 15 grams of carbohydrates 2. BG is 40-49 mg/dl, treatment is 30 grams of carbohydrates 15 min later, 2nd BG check, 2nd treatment 1. BG is 60-69 mg/dl, no treatment 2. BG is 50-59 mg/dl, treatment is 15 grams of carbohydrates 3. BG is \<50 mg/dl, treatment is participant's preferred oral carbohydrate and not mini-dose glucagon 30 minutes later, 3rd BG check, 3rd treatment 1. BG is \>=70 mg/dl, no treatment 2. BG is \<70 mg/dl, treatment is participant's preferred oral carbohydrate and not mini-dose glucagon
CGM Time in Range, Event Level	62 percentage of time Interval 42.0 to 79.0	67 percentage of time Interval 58.0 to 71.0

SECONDARY outcome

Timeframe: 60 Minutes

Population: A participant had to have sufficient calibrations using study BGM to compare BGM and CGM data to ensure matching dates and times. Event level requirements: 1) initial treatment and dose had to be correct, 2) ≥6 CGM readings within 1 hour after initial treatment, and 3) first CGM glucose after the start of the hypoglycemic event had to be \<80 mg/dL

Percentage of time <70 mg/dL from CGM data, following each hypoglycemic event with starting BG 50-69 mg/dL, during first hour after start of hypoglycemic event

Outcome measures

Measure	G-Pen Mini™ (Glucagon Injection) n=48 Hypoglycemic Events For G-Pen Mini period: Participants are to check blood glucose (BG) with study meter if continuous glucose monitor (CGM) reads \<70 mg/dl or they experience symptoms. Participants instructed to treat using mini-dose glucagon for certain phases/periods when BG is 40 to 69 mg/dl (considered a non-severe hypoglycemic event). G-Pen Mini™ (glucagon injection): 1st BG check, 1st treatment 1. BG is 50-69 mg/dl, treatment is 150 µg of glucagon 2. BG is 40-49 mg/dl, treatment is 300 µg of glucagon 15 min later, 2nd BG check, 2nd treatment 1. BG is 60-69 mg/dl, no treatment 2. BG is 50-59 mg/dl, treatment is 150 µg of glucagon 3. BG is \<50 mg/dl, treatment is participant's preferred oral carbohydrate and not mini-dose glucagon 30 minutes later, 3rd BG check, 3rd treatment 1. BG is \>=70, no treatment 2. BG is \<70 mg/dl, treatment is participant's preferred oral carbohydrate and not mini-dose glucagon	Glucose Tabs n=36 Hypoglycemic Events For Glucose Tabs Period: Participants are to check blood glucose (BG) with study meter if continuous glucose meter reads \<70 mg/dl or they experience symptoms. Participants instructed to treat using oral glucose tablets for certain phases/periods when BG is 40 to 69 mg/dl (considered a non-severe hypoglycemic event). Glucose Tabs: 1st BG check, 1st treatment: 1. BG is 50-69 mg/dl, treatment is 15 grams of carbohydrates 2. BG is 40-49 mg/dl, treatment is 30 grams of carbohydrates 15 min later, 2nd BG check, 2nd treatment 1. BG is 60-69 mg/dl, no treatment 2. BG is 50-59 mg/dl, treatment is 15 grams of carbohydrates 3. BG is \<50 mg/dl, treatment is participant's preferred oral carbohydrate and not mini-dose glucagon 30 minutes later, 3rd BG check, 3rd treatment 1. BG is \>=70 mg/dl, no treatment 2. BG is \<70 mg/dl, treatment is participant's preferred oral carbohydrate and not mini-dose glucagon
CGM Time Below 70 mg/dL, Event Level	35 percentage of time Interval 13.0 to 58.0	33 percentage of time Interval 26.0 to 42.0

SECONDARY outcome

Timeframe: 120 Minutes

Population: A participant had to have sufficient calibrations using study BGM to compare BGM and CGM data to ensure matching dates and times. Event level requirements: 1) initial treatment and dose had to be correct, 2) ≥6 CGM readings within 1 hour after initial treatment, and 3) first CGM glucose after the start of the hypoglycemic event had to be \<80 mg/dL

Minimum glucose from CGM data, following each hypoglycemic event with starting BG 50-69 mg/dL, during first 2 hours after start of hypoglycemic event

Outcome measures

Measure	G-Pen Mini™ (Glucagon Injection) n=48 Hypoglycemic Events For G-Pen Mini period: Participants are to check blood glucose (BG) with study meter if continuous glucose monitor (CGM) reads \<70 mg/dl or they experience symptoms. Participants instructed to treat using mini-dose glucagon for certain phases/periods when BG is 40 to 69 mg/dl (considered a non-severe hypoglycemic event). G-Pen Mini™ (glucagon injection): 1st BG check, 1st treatment 1. BG is 50-69 mg/dl, treatment is 150 µg of glucagon 2. BG is 40-49 mg/dl, treatment is 300 µg of glucagon 15 min later, 2nd BG check, 2nd treatment 1. BG is 60-69 mg/dl, no treatment 2. BG is 50-59 mg/dl, treatment is 150 µg of glucagon 3. BG is \<50 mg/dl, treatment is participant's preferred oral carbohydrate and not mini-dose glucagon 30 minutes later, 3rd BG check, 3rd treatment 1. BG is \>=70, no treatment 2. BG is \<70 mg/dl, treatment is participant's preferred oral carbohydrate and not mini-dose glucagon	Glucose Tabs n=36 Hypoglycemic Events For Glucose Tabs Period: Participants are to check blood glucose (BG) with study meter if continuous glucose meter reads \<70 mg/dl or they experience symptoms. Participants instructed to treat using oral glucose tablets for certain phases/periods when BG is 40 to 69 mg/dl (considered a non-severe hypoglycemic event). Glucose Tabs: 1st BG check, 1st treatment: 1. BG is 50-69 mg/dl, treatment is 15 grams of carbohydrates 2. BG is 40-49 mg/dl, treatment is 30 grams of carbohydrates 15 min later, 2nd BG check, 2nd treatment 1. BG is 60-69 mg/dl, no treatment 2. BG is 50-59 mg/dl, treatment is 15 grams of carbohydrates 3. BG is \<50 mg/dl, treatment is participant's preferred oral carbohydrate and not mini-dose glucagon 30 minutes later, 3rd BG check, 3rd treatment 1. BG is \>=70 mg/dl, no treatment 2. BG is \<70 mg/dl, treatment is participant's preferred oral carbohydrate and not mini-dose glucagon
CGM Minimum Glucose, Event Level	57 mg/dL Interval 51.0 to 65.0	56 mg/dL Interval 52.0 to 60.0

SECONDARY outcome

Timeframe: 120 Minutes

Population: A participant had to have sufficient calibrations using study BGM to compare BGM and CGM data to ensure matching dates and times. Event level requirements: 1) initial treatment and dose had to be correct, 2) ≥6 CGM readings within 1 hour after initial treatment, and 3) first CGM glucose after the start of the hypoglycemic event had to be \<80 mg/dL

Maximum glucose from CGM data, following each hypoglycemic event with starting BG 50-69 mg/dL, during first 2 hours after start of hypoglycemic event

Outcome measures

Measure	G-Pen Mini™ (Glucagon Injection) n=48 Hypoglycemic Events For G-Pen Mini period: Participants are to check blood glucose (BG) with study meter if continuous glucose monitor (CGM) reads \<70 mg/dl or they experience symptoms. Participants instructed to treat using mini-dose glucagon for certain phases/periods when BG is 40 to 69 mg/dl (considered a non-severe hypoglycemic event). G-Pen Mini™ (glucagon injection): 1st BG check, 1st treatment 1. BG is 50-69 mg/dl, treatment is 150 µg of glucagon 2. BG is 40-49 mg/dl, treatment is 300 µg of glucagon 15 min later, 2nd BG check, 2nd treatment 1. BG is 60-69 mg/dl, no treatment 2. BG is 50-59 mg/dl, treatment is 150 µg of glucagon 3. BG is \<50 mg/dl, treatment is participant's preferred oral carbohydrate and not mini-dose glucagon 30 minutes later, 3rd BG check, 3rd treatment 1. BG is \>=70, no treatment 2. BG is \<70 mg/dl, treatment is participant's preferred oral carbohydrate and not mini-dose glucagon	Glucose Tabs n=36 Hypoglycemic Events For Glucose Tabs Period: Participants are to check blood glucose (BG) with study meter if continuous glucose meter reads \<70 mg/dl or they experience symptoms. Participants instructed to treat using oral glucose tablets for certain phases/periods when BG is 40 to 69 mg/dl (considered a non-severe hypoglycemic event). Glucose Tabs: 1st BG check, 1st treatment: 1. BG is 50-69 mg/dl, treatment is 15 grams of carbohydrates 2. BG is 40-49 mg/dl, treatment is 30 grams of carbohydrates 15 min later, 2nd BG check, 2nd treatment 1. BG is 60-69 mg/dl, no treatment 2. BG is 50-59 mg/dl, treatment is 15 grams of carbohydrates 3. BG is \<50 mg/dl, treatment is participant's preferred oral carbohydrate and not mini-dose glucagon 30 minutes later, 3rd BG check, 3rd treatment 1. BG is \>=70 mg/dl, no treatment 2. BG is \<70 mg/dl, treatment is participant's preferred oral carbohydrate and not mini-dose glucagon
CGM Maximum Glucose, Event Level	122 mg/dL Interval 102.0 to 159.0	139 mg/dL Interval 116.0 to 161.0

SECONDARY outcome

Timeframe: 120 Minutes

Population: A participant had to have sufficient calibrations using study BGM to compare BGM and CGM data to ensure matching dates and times. Event level requirements: 1) initial treatment and dose had to be correct, 2) ≥6 CGM readings within 1 hour after initial treatment, and 3) first CGM glucose after the start of the hypoglycemic event had to be \<80 mg/dL

Median (IQR) reported for mean glucose from CGM data, following each hypoglycemic event with starting BG 50-69 mg/dL, during first 2 hours after start of hypoglycemic event

Outcome measures

Measure	G-Pen Mini™ (Glucagon Injection) n=48 Hypoglycemic Events For G-Pen Mini period: Participants are to check blood glucose (BG) with study meter if continuous glucose monitor (CGM) reads \<70 mg/dl or they experience symptoms. Participants instructed to treat using mini-dose glucagon for certain phases/periods when BG is 40 to 69 mg/dl (considered a non-severe hypoglycemic event). G-Pen Mini™ (glucagon injection): 1st BG check, 1st treatment 1. BG is 50-69 mg/dl, treatment is 150 µg of glucagon 2. BG is 40-49 mg/dl, treatment is 300 µg of glucagon 15 min later, 2nd BG check, 2nd treatment 1. BG is 60-69 mg/dl, no treatment 2. BG is 50-59 mg/dl, treatment is 150 µg of glucagon 3. BG is \<50 mg/dl, treatment is participant's preferred oral carbohydrate and not mini-dose glucagon 30 minutes later, 3rd BG check, 3rd treatment 1. BG is \>=70, no treatment 2. BG is \<70 mg/dl, treatment is participant's preferred oral carbohydrate and not mini-dose glucagon	Glucose Tabs n=36 Hypoglycemic Events For Glucose Tabs Period: Participants are to check blood glucose (BG) with study meter if continuous glucose meter reads \<70 mg/dl or they experience symptoms. Participants instructed to treat using oral glucose tablets for certain phases/periods when BG is 40 to 69 mg/dl (considered a non-severe hypoglycemic event). Glucose Tabs: 1st BG check, 1st treatment: 1. BG is 50-69 mg/dl, treatment is 15 grams of carbohydrates 2. BG is 40-49 mg/dl, treatment is 30 grams of carbohydrates 15 min later, 2nd BG check, 2nd treatment 1. BG is 60-69 mg/dl, no treatment 2. BG is 50-59 mg/dl, treatment is 15 grams of carbohydrates 3. BG is \<50 mg/dl, treatment is participant's preferred oral carbohydrate and not mini-dose glucagon 30 minutes later, 3rd BG check, 3rd treatment 1. BG is \>=70 mg/dl, no treatment 2. BG is \<70 mg/dl, treatment is participant's preferred oral carbohydrate and not mini-dose glucagon
CGM Mean Glucose, Event Level	95 mg/dL Interval 77.0 to 113.0	108 mg/dL Interval 89.0 to 119.0

SECONDARY outcome

Timeframe: 120 Minutes

Population: A participant had to have sufficient calibrations using study BGM to compare BGM and CGM data to ensure matching dates and times. Event level requirements: 1) initial treatment and dose had to be correct, 2) ≥6 CGM readings within 1 hour after initial treatment, and 3) first CGM glucose after the start of the hypoglycemic event had to be \<80 mg/dL

Percentage of time 70-180 mg/dL from CGM data, following each hypoglycemic event with starting BG 50-69 mg/dL, during first 2 hours after start of hypoglycemic event

Outcome measures

Measure	G-Pen Mini™ (Glucagon Injection) n=48 Hypoglycemic Events For G-Pen Mini period: Participants are to check blood glucose (BG) with study meter if continuous glucose monitor (CGM) reads \<70 mg/dl or they experience symptoms. Participants instructed to treat using mini-dose glucagon for certain phases/periods when BG is 40 to 69 mg/dl (considered a non-severe hypoglycemic event). G-Pen Mini™ (glucagon injection): 1st BG check, 1st treatment 1. BG is 50-69 mg/dl, treatment is 150 µg of glucagon 2. BG is 40-49 mg/dl, treatment is 300 µg of glucagon 15 min later, 2nd BG check, 2nd treatment 1. BG is 60-69 mg/dl, no treatment 2. BG is 50-59 mg/dl, treatment is 150 µg of glucagon 3. BG is \<50 mg/dl, treatment is participant's preferred oral carbohydrate and not mini-dose glucagon 30 minutes later, 3rd BG check, 3rd treatment 1. BG is \>=70, no treatment 2. BG is \<70 mg/dl, treatment is participant's preferred oral carbohydrate and not mini-dose glucagon	Glucose Tabs n=36 Hypoglycemic Events For Glucose Tabs Period: Participants are to check blood glucose (BG) with study meter if continuous glucose meter reads \<70 mg/dl or they experience symptoms. Participants instructed to treat using oral glucose tablets for certain phases/periods when BG is 40 to 69 mg/dl (considered a non-severe hypoglycemic event). Glucose Tabs: 1st BG check, 1st treatment: 1. BG is 50-69 mg/dl, treatment is 15 grams of carbohydrates 2. BG is 40-49 mg/dl, treatment is 30 grams of carbohydrates 15 min later, 2nd BG check, 2nd treatment 1. BG is 60-69 mg/dl, no treatment 2. BG is 50-59 mg/dl, treatment is 15 grams of carbohydrates 3. BG is \<50 mg/dl, treatment is participant's preferred oral carbohydrate and not mini-dose glucagon 30 minutes later, 3rd BG check, 3rd treatment 1. BG is \>=70 mg/dl, no treatment 2. BG is \<70 mg/dl, treatment is participant's preferred oral carbohydrate and not mini-dose glucagon
CGM Time in Range, Event Level	79 percentage of time Interval 50.0 to 88.0	79 percentage of time Interval 69.0 to 86.0

SECONDARY outcome

Timeframe: 120 Minutes

Population: A participant had to have sufficient calibrations using study BGM to compare BGM and CGM data to ensure matching dates and times. Event level requirements: 1) initial treatment and dose had to be correct, 2) ≥6 CGM readings within 1 hour after initial treatment, and 3) first CGM glucose after the start of the hypoglycemic event had to be \<80 mg/dL

Percentage of time <70 mg/dL from CGM data, following each hypoglycemic event with starting BG 50-69 mg/dL, during first 2 hours after start of hypoglycemic event

Outcome measures

Measure	G-Pen Mini™ (Glucagon Injection) n=48 Hypoglycemic Events For G-Pen Mini period: Participants are to check blood glucose (BG) with study meter if continuous glucose monitor (CGM) reads \<70 mg/dl or they experience symptoms. Participants instructed to treat using mini-dose glucagon for certain phases/periods when BG is 40 to 69 mg/dl (considered a non-severe hypoglycemic event). G-Pen Mini™ (glucagon injection): 1st BG check, 1st treatment 1. BG is 50-69 mg/dl, treatment is 150 µg of glucagon 2. BG is 40-49 mg/dl, treatment is 300 µg of glucagon 15 min later, 2nd BG check, 2nd treatment 1. BG is 60-69 mg/dl, no treatment 2. BG is 50-59 mg/dl, treatment is 150 µg of glucagon 3. BG is \<50 mg/dl, treatment is participant's preferred oral carbohydrate and not mini-dose glucagon 30 minutes later, 3rd BG check, 3rd treatment 1. BG is \>=70, no treatment 2. BG is \<70 mg/dl, treatment is participant's preferred oral carbohydrate and not mini-dose glucagon	Glucose Tabs n=36 Hypoglycemic Events For Glucose Tabs Period: Participants are to check blood glucose (BG) with study meter if continuous glucose meter reads \<70 mg/dl or they experience symptoms. Participants instructed to treat using oral glucose tablets for certain phases/periods when BG is 40 to 69 mg/dl (considered a non-severe hypoglycemic event). Glucose Tabs: 1st BG check, 1st treatment: 1. BG is 50-69 mg/dl, treatment is 15 grams of carbohydrates 2. BG is 40-49 mg/dl, treatment is 30 grams of carbohydrates 15 min later, 2nd BG check, 2nd treatment 1. BG is 60-69 mg/dl, no treatment 2. BG is 50-59 mg/dl, treatment is 15 grams of carbohydrates 3. BG is \<50 mg/dl, treatment is participant's preferred oral carbohydrate and not mini-dose glucagon 30 minutes later, 3rd BG check, 3rd treatment 1. BG is \>=70 mg/dl, no treatment 2. BG is \<70 mg/dl, treatment is participant's preferred oral carbohydrate and not mini-dose glucagon
CGM Time Below 70 mg/dL	20 percentage of time Interval 9.0 to 40.0	19 percentage of time Interval 13.0 to 25.0

SECONDARY outcome

Timeframe: 3 weeks

Population: Limited to participants who had at least 72 hours of CGM data during each period

Median (IQR) reported for mean glucose from CGM data computed over entire 3 weeks of treatment period

Outcome measures

Measure	G-Pen Mini™ (Glucagon Injection) n=15 Participants For G-Pen Mini period: Participants are to check blood glucose (BG) with study meter if continuous glucose monitor (CGM) reads \<70 mg/dl or they experience symptoms. Participants instructed to treat using mini-dose glucagon for certain phases/periods when BG is 40 to 69 mg/dl (considered a non-severe hypoglycemic event). G-Pen Mini™ (glucagon injection): 1st BG check, 1st treatment 1. BG is 50-69 mg/dl, treatment is 150 µg of glucagon 2. BG is 40-49 mg/dl, treatment is 300 µg of glucagon 15 min later, 2nd BG check, 2nd treatment 1. BG is 60-69 mg/dl, no treatment 2. BG is 50-59 mg/dl, treatment is 150 µg of glucagon 3. BG is \<50 mg/dl, treatment is participant's preferred oral carbohydrate and not mini-dose glucagon 30 minutes later, 3rd BG check, 3rd treatment 1. BG is \>=70, no treatment 2. BG is \<70 mg/dl, treatment is participant's preferred oral carbohydrate and not mini-dose glucagon	Glucose Tabs n=15 Participants For Glucose Tabs Period: Participants are to check blood glucose (BG) with study meter if continuous glucose meter reads \<70 mg/dl or they experience symptoms. Participants instructed to treat using oral glucose tablets for certain phases/periods when BG is 40 to 69 mg/dl (considered a non-severe hypoglycemic event). Glucose Tabs: 1st BG check, 1st treatment: 1. BG is 50-69 mg/dl, treatment is 15 grams of carbohydrates 2. BG is 40-49 mg/dl, treatment is 30 grams of carbohydrates 15 min later, 2nd BG check, 2nd treatment 1. BG is 60-69 mg/dl, no treatment 2. BG is 50-59 mg/dl, treatment is 15 grams of carbohydrates 3. BG is \<50 mg/dl, treatment is participant's preferred oral carbohydrate and not mini-dose glucagon 30 minutes later, 3rd BG check, 3rd treatment 1. BG is \>=70 mg/dl, no treatment 2. BG is \<70 mg/dl, treatment is participant's preferred oral carbohydrate and not mini-dose glucagon
CGM Mean Glucose	143 mg/dL Interval 135.0 to 169.0	149 mg/dL Interval 136.0 to 177.0

SECONDARY outcome

Timeframe: 3 weeks

Population: Limited to participants who had at least 72 hours of CGM data during each period

Percentage of time 70-180 mg/dL from CGM data computed over entire 3 weeks of treatment period

Outcome measures

Measure	G-Pen Mini™ (Glucagon Injection) n=15 Participants For G-Pen Mini period: Participants are to check blood glucose (BG) with study meter if continuous glucose monitor (CGM) reads \<70 mg/dl or they experience symptoms. Participants instructed to treat using mini-dose glucagon for certain phases/periods when BG is 40 to 69 mg/dl (considered a non-severe hypoglycemic event). G-Pen Mini™ (glucagon injection): 1st BG check, 1st treatment 1. BG is 50-69 mg/dl, treatment is 150 µg of glucagon 2. BG is 40-49 mg/dl, treatment is 300 µg of glucagon 15 min later, 2nd BG check, 2nd treatment 1. BG is 60-69 mg/dl, no treatment 2. BG is 50-59 mg/dl, treatment is 150 µg of glucagon 3. BG is \<50 mg/dl, treatment is participant's preferred oral carbohydrate and not mini-dose glucagon 30 minutes later, 3rd BG check, 3rd treatment 1. BG is \>=70, no treatment 2. BG is \<70 mg/dl, treatment is participant's preferred oral carbohydrate and not mini-dose glucagon	Glucose Tabs n=15 Participants For Glucose Tabs Period: Participants are to check blood glucose (BG) with study meter if continuous glucose meter reads \<70 mg/dl or they experience symptoms. Participants instructed to treat using oral glucose tablets for certain phases/periods when BG is 40 to 69 mg/dl (considered a non-severe hypoglycemic event). Glucose Tabs: 1st BG check, 1st treatment: 1. BG is 50-69 mg/dl, treatment is 15 grams of carbohydrates 2. BG is 40-49 mg/dl, treatment is 30 grams of carbohydrates 15 min later, 2nd BG check, 2nd treatment 1. BG is 60-69 mg/dl, no treatment 2. BG is 50-59 mg/dl, treatment is 15 grams of carbohydrates 3. BG is \<50 mg/dl, treatment is participant's preferred oral carbohydrate and not mini-dose glucagon 30 minutes later, 3rd BG check, 3rd treatment 1. BG is \>=70 mg/dl, no treatment 2. BG is \<70 mg/dl, treatment is participant's preferred oral carbohydrate and not mini-dose glucagon
CGM Time in Range	71 percentage of time Interval 60.0 to 79.0	71 percentage of time Interval 57.0 to 79.0

SECONDARY outcome

Timeframe: 3 weeks

Population: Limited to participants who had at least 72 hours of CGM data during each period

Percentage of time <70 mg/dL from CGM data computed over entire 3 weeks of treatment period

Outcome measures

Measure	G-Pen Mini™ (Glucagon Injection) n=15 Participants For G-Pen Mini period: Participants are to check blood glucose (BG) with study meter if continuous glucose monitor (CGM) reads \<70 mg/dl or they experience symptoms. Participants instructed to treat using mini-dose glucagon for certain phases/periods when BG is 40 to 69 mg/dl (considered a non-severe hypoglycemic event). G-Pen Mini™ (glucagon injection): 1st BG check, 1st treatment 1. BG is 50-69 mg/dl, treatment is 150 µg of glucagon 2. BG is 40-49 mg/dl, treatment is 300 µg of glucagon 15 min later, 2nd BG check, 2nd treatment 1. BG is 60-69 mg/dl, no treatment 2. BG is 50-59 mg/dl, treatment is 150 µg of glucagon 3. BG is \<50 mg/dl, treatment is participant's preferred oral carbohydrate and not mini-dose glucagon 30 minutes later, 3rd BG check, 3rd treatment 1. BG is \>=70, no treatment 2. BG is \<70 mg/dl, treatment is participant's preferred oral carbohydrate and not mini-dose glucagon	Glucose Tabs n=15 Participants For Glucose Tabs Period: Participants are to check blood glucose (BG) with study meter if continuous glucose meter reads \<70 mg/dl or they experience symptoms. Participants instructed to treat using oral glucose tablets for certain phases/periods when BG is 40 to 69 mg/dl (considered a non-severe hypoglycemic event). Glucose Tabs: 1st BG check, 1st treatment: 1. BG is 50-69 mg/dl, treatment is 15 grams of carbohydrates 2. BG is 40-49 mg/dl, treatment is 30 grams of carbohydrates 15 min later, 2nd BG check, 2nd treatment 1. BG is 60-69 mg/dl, no treatment 2. BG is 50-59 mg/dl, treatment is 15 grams of carbohydrates 3. BG is \<50 mg/dl, treatment is participant's preferred oral carbohydrate and not mini-dose glucagon 30 minutes later, 3rd BG check, 3rd treatment 1. BG is \>=70 mg/dl, no treatment 2. BG is \<70 mg/dl, treatment is participant's preferred oral carbohydrate and not mini-dose glucagon
CGM Time Below 70	5 percentage of time Interval 2.0 to 7.0	4 percentage of time Interval 2.0 to 6.0

SECONDARY outcome

Timeframe: 3 weeks

Population: Limited to participants who had at least 72 hours of CGM data during each period

Coefficient of Variation from CGM data computed over entire 3 weeks of treatment period

Outcome measures

Measure	G-Pen Mini™ (Glucagon Injection) n=15 Participants For G-Pen Mini period: Participants are to check blood glucose (BG) with study meter if continuous glucose monitor (CGM) reads \<70 mg/dl or they experience symptoms. Participants instructed to treat using mini-dose glucagon for certain phases/periods when BG is 40 to 69 mg/dl (considered a non-severe hypoglycemic event). G-Pen Mini™ (glucagon injection): 1st BG check, 1st treatment 1. BG is 50-69 mg/dl, treatment is 150 µg of glucagon 2. BG is 40-49 mg/dl, treatment is 300 µg of glucagon 15 min later, 2nd BG check, 2nd treatment 1. BG is 60-69 mg/dl, no treatment 2. BG is 50-59 mg/dl, treatment is 150 µg of glucagon 3. BG is \<50 mg/dl, treatment is participant's preferred oral carbohydrate and not mini-dose glucagon 30 minutes later, 3rd BG check, 3rd treatment 1. BG is \>=70, no treatment 2. BG is \<70 mg/dl, treatment is participant's preferred oral carbohydrate and not mini-dose glucagon	Glucose Tabs n=15 Participants For Glucose Tabs Period: Participants are to check blood glucose (BG) with study meter if continuous glucose meter reads \<70 mg/dl or they experience symptoms. Participants instructed to treat using oral glucose tablets for certain phases/periods when BG is 40 to 69 mg/dl (considered a non-severe hypoglycemic event). Glucose Tabs: 1st BG check, 1st treatment: 1. BG is 50-69 mg/dl, treatment is 15 grams of carbohydrates 2. BG is 40-49 mg/dl, treatment is 30 grams of carbohydrates 15 min later, 2nd BG check, 2nd treatment 1. BG is 60-69 mg/dl, no treatment 2. BG is 50-59 mg/dl, treatment is 15 grams of carbohydrates 3. BG is \<50 mg/dl, treatment is participant's preferred oral carbohydrate and not mini-dose glucagon 30 minutes later, 3rd BG check, 3rd treatment 1. BG is \>=70 mg/dl, no treatment 2. BG is \<70 mg/dl, treatment is participant's preferred oral carbohydrate and not mini-dose glucagon
CGM Coefficient of Variation	35 percentage coefficient of variation Interval 33.0 to 40.0	36 percentage coefficient of variation Interval 35.0 to 39.0

POST_HOC outcome

Timeframe: 60 minutes

Population: Analysis was limited to hypoglycemic events included in the primary analysis. 3 hypoglycemic events were deemed Indeterminate by the graders during the glucagon period.

2 graders, blinded to treatment arm, independently graded each hypoglycemic event as a clinical failure or success based on all available BG concentrations within 1 hour of initial treatment. All BG values, along with corresponding time elapsed since treatment, were reviewed to determine whether the response would be considered a treatment success, in a clinical setting. There were no specific cut points; rather than basing the success criteria on whether the BG was above specific cutpoints by specific times, the grader decided whether the event would be considered a success in a clinical setting (i.e. if the BG increased after treatment and reached and maintained a satisfactory level after the treatment). The graders to achieve a consensus grading adjudicated discordant gradings (6% of events). The number of events graded as a treatment success were reported out of the total number of hypoglycemic events, for each treatment arm.

Outcome measures

Measure	G-Pen Mini™ (Glucagon Injection) n=59 Hypoglycemic Events For G-Pen Mini period: Participants are to check blood glucose (BG) with study meter if continuous glucose monitor (CGM) reads \<70 mg/dl or they experience symptoms. Participants instructed to treat using mini-dose glucagon for certain phases/periods when BG is 40 to 69 mg/dl (considered a non-severe hypoglycemic event). G-Pen Mini™ (glucagon injection): 1st BG check, 1st treatment 1. BG is 50-69 mg/dl, treatment is 150 µg of glucagon 2. BG is 40-49 mg/dl, treatment is 300 µg of glucagon 15 min later, 2nd BG check, 2nd treatment 1. BG is 60-69 mg/dl, no treatment 2. BG is 50-59 mg/dl, treatment is 150 µg of glucagon 3. BG is \<50 mg/dl, treatment is participant's preferred oral carbohydrate and not mini-dose glucagon 30 minutes later, 3rd BG check, 3rd treatment 1. BG is \>=70, no treatment 2. BG is \<70 mg/dl, treatment is participant's preferred oral carbohydrate and not mini-dose glucagon	Glucose Tabs n=56 Hypoglycemic Events For Glucose Tabs Period: Participants are to check blood glucose (BG) with study meter if continuous glucose meter reads \<70 mg/dl or they experience symptoms. Participants instructed to treat using oral glucose tablets for certain phases/periods when BG is 40 to 69 mg/dl (considered a non-severe hypoglycemic event). Glucose Tabs: 1st BG check, 1st treatment: 1. BG is 50-69 mg/dl, treatment is 15 grams of carbohydrates 2. BG is 40-49 mg/dl, treatment is 30 grams of carbohydrates 15 min later, 2nd BG check, 2nd treatment 1. BG is 60-69 mg/dl, no treatment 2. BG is 50-59 mg/dl, treatment is 15 grams of carbohydrates 3. BG is \<50 mg/dl, treatment is participant's preferred oral carbohydrate and not mini-dose glucagon 30 minutes later, 3rd BG check, 3rd treatment 1. BG is \>=70 mg/dl, no treatment 2. BG is \<70 mg/dl, treatment is participant's preferred oral carbohydrate and not mini-dose glucagon
Clinical Grading - Limited to Events in Primary Analysis	57 Hypoglycemic Events	54 Hypoglycemic Events

POST_HOC outcome

Timeframe: 60 minutes

Population: Analysis was limited to hypoglycemic events where Initial and 15-min Treatment were correct. 4 hypoglycemic events were deemed Indeterminate by the graders during the glucagon period.

2 graders, blinded to treatment arm, independently graded each hypoglycemic event as a clinical failure or success based on all available BG concentrations within 1 hour of initial treatment. All BG values, along with corresponding time elapsed since treatment, were reviewed to determine whether the response would be considered a treatment success, in a clinical setting. There were no specific cut points; rather than basing the success criteria on whether the BG was above specific cutpoints by specific times, the grader decided whether the event would be considered a success in a clinical setting (i.e. if the BG increased after treatment and reached and maintained a satisfactory level after the treatment). The graders to achieve a consensus grading adjudicated discordant gradings (6% of events). The number of events graded as a treatment success were reported out of the total number of hypoglycemic events, for each treatment arm.

Outcome measures

Measure	G-Pen Mini™ (Glucagon Injection) n=69 Hypoglycemic Events For G-Pen Mini period: Participants are to check blood glucose (BG) with study meter if continuous glucose monitor (CGM) reads \<70 mg/dl or they experience symptoms. Participants instructed to treat using mini-dose glucagon for certain phases/periods when BG is 40 to 69 mg/dl (considered a non-severe hypoglycemic event). G-Pen Mini™ (glucagon injection): 1st BG check, 1st treatment 1. BG is 50-69 mg/dl, treatment is 150 µg of glucagon 2. BG is 40-49 mg/dl, treatment is 300 µg of glucagon 15 min later, 2nd BG check, 2nd treatment 1. BG is 60-69 mg/dl, no treatment 2. BG is 50-59 mg/dl, treatment is 150 µg of glucagon 3. BG is \<50 mg/dl, treatment is participant's preferred oral carbohydrate and not mini-dose glucagon 30 minutes later, 3rd BG check, 3rd treatment 1. BG is \>=70, no treatment 2. BG is \<70 mg/dl, treatment is participant's preferred oral carbohydrate and not mini-dose glucagon	Glucose Tabs n=67 Hypoglycemic Events For Glucose Tabs Period: Participants are to check blood glucose (BG) with study meter if continuous glucose meter reads \<70 mg/dl or they experience symptoms. Participants instructed to treat using oral glucose tablets for certain phases/periods when BG is 40 to 69 mg/dl (considered a non-severe hypoglycemic event). Glucose Tabs: 1st BG check, 1st treatment: 1. BG is 50-69 mg/dl, treatment is 15 grams of carbohydrates 2. BG is 40-49 mg/dl, treatment is 30 grams of carbohydrates 15 min later, 2nd BG check, 2nd treatment 1. BG is 60-69 mg/dl, no treatment 2. BG is 50-59 mg/dl, treatment is 15 grams of carbohydrates 3. BG is \<50 mg/dl, treatment is participant's preferred oral carbohydrate and not mini-dose glucagon 30 minutes later, 3rd BG check, 3rd treatment 1. BG is \>=70 mg/dl, no treatment 2. BG is \<70 mg/dl, treatment is participant's preferred oral carbohydrate and not mini-dose glucagon
Clinical Grading - Initial and 15-min Treatment Correct	66 Hypoglycemic Events	63 Hypoglycemic Events

POST_HOC outcome

Timeframe: 60 minutes

Population: This analysis included all hypoglycemic events in which the initial treatment and dose were correct, irrespective of the timing of the BG measurements. 8 hypoglycemic events were deemed Indeterminate by the graders during the glucagon period and 4 during the glucose tabs period.

2 graders, blinded to treatment arm, independently graded each hypoglycemic event as a clinical failure or success based on all available BG concentrations within 1 hour of initial treatment. All BG values, along with corresponding time elapsed since treatment, were reviewed to determine whether the response would be considered a treatment success, in a clinical setting. There were no specific cut points; rather than basing the success criteria on whether the BG was above specific cutpoints by specific times, the grader decided whether the event would be considered a success in a clinical setting (i.e. if the BG increased after treatment and reached and maintained a satisfactory level after the treatment). The graders to achieve a consensus grading adjudicated discordant gradings (6% of events). The number of events graded as a treatment success were reported out of the total number of hypoglycemic events, for each treatment arm.

Outcome measures

Measure	G-Pen Mini™ (Glucagon Injection) n=95 Hypoglycemic Events For G-Pen Mini period: Participants are to check blood glucose (BG) with study meter if continuous glucose monitor (CGM) reads \<70 mg/dl or they experience symptoms. Participants instructed to treat using mini-dose glucagon for certain phases/periods when BG is 40 to 69 mg/dl (considered a non-severe hypoglycemic event). G-Pen Mini™ (glucagon injection): 1st BG check, 1st treatment 1. BG is 50-69 mg/dl, treatment is 150 µg of glucagon 2. BG is 40-49 mg/dl, treatment is 300 µg of glucagon 15 min later, 2nd BG check, 2nd treatment 1. BG is 60-69 mg/dl, no treatment 2. BG is 50-59 mg/dl, treatment is 150 µg of glucagon 3. BG is \<50 mg/dl, treatment is participant's preferred oral carbohydrate and not mini-dose glucagon 30 minutes later, 3rd BG check, 3rd treatment 1. BG is \>=70, no treatment 2. BG is \<70 mg/dl, treatment is participant's preferred oral carbohydrate and not mini-dose glucagon	Glucose Tabs n=92 Hypoglycemic Events For Glucose Tabs Period: Participants are to check blood glucose (BG) with study meter if continuous glucose meter reads \<70 mg/dl or they experience symptoms. Participants instructed to treat using oral glucose tablets for certain phases/periods when BG is 40 to 69 mg/dl (considered a non-severe hypoglycemic event). Glucose Tabs: 1st BG check, 1st treatment: 1. BG is 50-69 mg/dl, treatment is 15 grams of carbohydrates 2. BG is 40-49 mg/dl, treatment is 30 grams of carbohydrates 15 min later, 2nd BG check, 2nd treatment 1. BG is 60-69 mg/dl, no treatment 2. BG is 50-59 mg/dl, treatment is 15 grams of carbohydrates 3. BG is \<50 mg/dl, treatment is participant's preferred oral carbohydrate and not mini-dose glucagon 30 minutes later, 3rd BG check, 3rd treatment 1. BG is \>=70 mg/dl, no treatment 2. BG is \<70 mg/dl, treatment is participant's preferred oral carbohydrate and not mini-dose glucagon
Clinical Grading - Initial Treatment Correct	84 Hypoglycemic Events	88 Hypoglycemic Events

Adverse Events

G-Pen Mini™ (Glucagon Injection)

Serious events: 0 serious events

Other events: 2 other events

Deaths: 0 deaths

Glucose Tabs

Serious events: 0 serious events

Other events: 1 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Measure	G-Pen Mini™ (Glucagon Injection) n=20 participants at risk Participants treat non-severe hypoglycemic events with glucagon.	Glucose Tabs n=20 participants at risk Participants treat non-severe hypoglycemic events with glucose tabs.
Pregnancy, puerperium and perinatal conditions Unintended Pregnancy	5.0% 1/20 • Number of events 1 • Adverse events were collected through study completion, an average of 12 weeks.	0.00% 0/20 • Adverse events were collected through study completion, an average of 12 weeks.
Respiratory, thoracic and mediastinal disorders Upper Respiratory Infection	5.0% 1/20 • Number of events 1 • Adverse events were collected through study completion, an average of 12 weeks.	0.00% 0/20 • Adverse events were collected through study completion, an average of 12 weeks.
Respiratory, thoracic and mediastinal disorders Streptococcal Sore Throat	5.0% 1/20 • Number of events 1 • Adverse events were collected through study completion, an average of 12 weeks.	5.0% 1/20 • Number of events 1 • Adverse events were collected through study completion, an average of 12 weeks.

Additional Information

Stephanie DuBose

Jaeb Center for Health Research

Phone: 813-975-8690

Email: t1dstats2@jaeb.org

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place